Kennedy’s Disease Tissue Donation Program
Spinal Bulbar Muscular Atrophy
(aka Kennedy’s Disease)
Tissue Donation Program
Facilitated by:
Kennedy’s Disease Association
P.O. Box 1105
Coarsegold,CA93614-1105
(559) 658-5950
Email:
Bldg. 22 Room 105A
AAVA Research 151
2215 Fuller Road
Ann Arbor MI 48105-2399
P: +(734)845-5244
Pager: 734-936-6267 – pager # 9198
Email:
Website:
Keep this booklet in a safe place known by several family members
Revised October, 2013
Table of Contents
About the Tissue Donation Program ...... 3
About the KDA
The KDA’s Scientific Review Board
Questions about Donating Tissue
1.What research will be done on the collected tissue?
2.What tissue is collected?
3.Is patient confidentiality maintained?
4.Will the funeral arrangements be delayed?
5.Can there still be an open casket?
6.Do I have to tell my relatives that the tissue has been removed?
7.Does donating tissue for research purposes interfere with religious beliefs?
8.Who can legally grant permission for the tissue to be removed?
9.Will genetic analysis be performed?
10.If genetic analysis is performed, will anyone be informed of the results?
11.Where is the tissue collection done?
12.Are there any costs or fees involved?
13.Will the Tissue Bank Coordinator help make the collection arrangements?
14.Where is the tissue stored?
15.When should pre-arrangements for a tissue donation be made?
16.What if a member of my family is opposed to the tissue donation?
17.What needs to be done when I have made a decision to become a donor?
18.How do we minimize any last minute decisions or conflicts?
19.What tissue will be harvested?
What Needs To Be Done At The Time Of Death?
The Forms You Need
FORM A
FORM B
FORM C
FORM D
FORM E
Important Telephone Numbers
About the Tissue Donation Program
Spinal Bulbar Muscular Atrophy, aka Kennedy’s Disease, is considered a rare disorder. Less than 1-in-40,000 people have the defective gene. Most research is performed on fruit flies and mice models. Until recently, human tissue was not available for testing in research labs. Today, tissue donated from an individual with Kennedy’s Disease is being used in several labs. This human tissue is very helpful in studying the biology as well as the effects of the disease. The KDA’s Scientific Review Board feels that the availability of additional human tissue will benefit research and might help find a treatment for Kennedy’s Disease.
About the KDA
The Kennedy's Disease Association is a non-profit California corporation.The KDA is recognized under United States of America Internal Revenue Code 501(c)3 as a publicly supported organization as described in sections 509(a)1 and 170(b)1(A)(vi).
The Kennedy's Disease Association was formed with the following objectives in mind:
1. To put those living with Kennedy's Disease in touch with others for support
2. To share information in regards to Kennedy's Disease for those who seek it
3. To raise awareness in both the medical and public communities
4. To raise funding for research and awareness campaigns
The KDA’sScientific Review Board
Kenneth Fischbeck, MD, PhD - National Institute of Neurological Diseases and Stroke
A leading researcher, professor, and educator on the subject of Kennedy's Disease; a co-discoverer of the Spinal Bulbar Muscular Atrophy gene.
Diane Merry, PhD - Thomas Jefferson University
Leads a dedicatedresearch team focused onKennedy’s Disease.
Al La Spada, MD, PhD - University of California, San Diego
Co-discovered the Spinal Bulbar Muscular Atrophy gene and continues to research Kennedy's Disease.
J. Paul Taylor, MD, PhD–St. Jude Children’s Research Hospital
Leads a team that studies neurodegenerative diseasesincluding Kennedy's Disease.
Andrew P. Lieberman, MD, PhD–University of Michigan Health System
Leads a team that studies the pathogenesis of inherited neurodegenerative diseases including Kennedy's Disease.
Ed Meyertholen- Research Liaison
Assistant Dean and Director of Pre-Health Programs at Georgetown College, Georgetown University and an individual living with Kennedy's Disease.
Todd Allen-Patient Liaison
An individual living with Kennedy’s Disease who supports Kennedy's Disease Research
Note: Preplanning is required to minimize last minute decisions and possible delays. Finding a qualified pathologist ahead of time is especially important.
QuestionsaboutDonating Tissue
- What research will be done on the collected tissue?
Tissue samples and results of clinical testing are made available to qualified scientists only after their researchproposal is reviewed and approved by the Kennedy’s Disease Associations (KDA) Scientific Review Board (SRB). These studies may lead to improvedunderstanding and advances in the diagnosis and treatment of Kennedy's Disease and relateddisorders. Samples are provided for biochemical and genetic studies. The samples are labeled withnumbers rather than names to keep information anonymous.
- What tissue is collected?
Brain and spinal cord (with attached dorsal root ganglia) are the minimal tissues that will be collected from patients with Kennedy’s Disease. Other tissues, such as testes and skeletal muscle, could also be useful to researchers and will be collected if permission is received from the next of kin.
- Is patient confidentiality maintained?
Yes. Patient confidentiality is strictly maintained by the autopsy service, hospital and tissue bank. An autopsy number assigned at the time tissue is submitted to the tissue bank is the only identifier of tissues provided to researchers. This assigned number is devoid of all private information, such as name, address, or other personal identification numbers.
- Will the funeral arrangements be delayed?
No, with preplanning and careful coordination, there should be no delays for typical funeralarrangements. The tissue collection procedure will be performed within the first 24 hours after death. A family member needs to be able to work with the hospital, nursing home, or funeral home to expedite the transportation from the place ofdeath to the Medical Center or hospital, and after the collection then to the funeral home. Completion ofForms A (or B)and C located in the back of this booklet before the time of death and Form D at the time of death will assist in preventing any delays.
- Can there still be an open casket?
Yes. The removal of tissue does not change the appearance of the body for the funeral service.
- Do I have to tell my relatives that the tissue has been removed?
No, you do not have to tell anyone if you do not wish.
- Does donating tissue for research purposes interfere with religious beliefs?
No, tissue donation does not conflict with most religious beliefs. If you have any questionsconcerning this issue, please contact your priest, minister, imam, rabbi, or other religious leader.
- Who can legally grant permission for the tissue to be removed?
Prior to death, an individual donor or family member can indicate their intent by signing the provisionalconsent. This permits your doctor to plan for the tissue collection. However, after death, the person's legal next-of-kin must authorize the tissue removal before it can be performed. The following persons, in order ofpriority, may provide such consent:
1) Spouse
2) An adult son or daughter(*)
3) Either parent
4) An adult brother or sister(*)
5) A guardian of the decedent at the time of death.(*)
6) Any other person legally authorized.
(*) Note: The person must be at least 18 years old
If there are several individuals in a category, they must all agree. For example,forpriority level 2 above, all adult children have equal authority and must agree. Signing a provisional consent can help others by documenting a patient's wishes.
- Will genetic analysis be performed?
Possibly, genetic tests may be performed on collected tissue at the discretion of the researcher. Since no patient identifiers are provided with the tissue, the results of these tests will remain anonymous.
- If genetic analysis is performed, will anyone be informed of the results?
No, results of genetic tests, like other research results, are kept confidential to the full extent of the law. Genetic test results are shared withother researchers when appropriate. In these cases, since no patient identifiers are provided with the tissue, the results of these tests will remain anonymous.
- Where is the tissue collection done?
The next of kin and family doctor determine this. It is most helpful for the donor and family to make pre-arrangements with a pathologist at a nearby medical center or university hospital to collect the tissue. Your family doctor should be able to recommend a facility in your area that can perform this service. Autopsies at community hospitals are not performed regularly, but academic medical centers are generally more receptive to the procedure. Once an autopsy is agreed to and arranged and upon the request of the donor or authorized family member, a member of the KDA’s Scientific Review Board can become involved by speaking with the pathologist and advising what tissue should be harvested for banking.
- Are there any costs or fees involved?
Yes, the family will be responsible for any costs related to the actual tissue collection process as well as the transportation costs to and from the medical center or university hospital where the tissue is collected. There is no charge for the shipping of the tissue collected, the tissue storage, or for any of the research testing.
- Will the Tissue Bank Coordinator help make the collection arrangements?
No, unfortunately the KDA andTissue Bank Coordinatorare not able to help the family locate a medical center and pathologist toperform the tissue collection. The coordinator, however, will work closely with you to facilitate arrangements to transfer the harvested tissue from the hospital or medical center to the tissue bank. A member of the KDA’s Scientific Review Board could also be made available to help answer any questions that the pathologist may have providing that the KDA has advanced notice of an impending death and autopsy.
- Where is the tissue stored?
The tissue will be stored at a tissue or organ storage facility. Currently, that location is at the University of Michigan Brain Bank.
- When should pre-arrangements for a tissue donation be made?
Planning should begin as soon as your decision is reached. Preferably, tissue donation preparations shouldbemade before the time of death. To indicate your intent for a tissue donation, you shouldcomplete and sign either Form A or B in this booklet and return it to the KDA and the University of Michigan Brain Bank.
Form A or B simply indicates your intent to make the tissue donation arrangements. Theform itself is not legally binding. It only serves as notice to the KDA of your desire to donate tissue. The actual tissue collection consent must be given at the time ofdeath by the legal next-of-kin. Upon completion of either Form A or B, a copy should be sent to your next of kin, your family doctor, the intended executor of the estate, the agent under Medical Power of Attorney, and the KDA.
Important: Your decision to donate tissue should be shared with the immediate family, the appointed legal guardian, medical caregivers, the intended executor of the estate, the agent under Medical Power of Attorney, and your funeral director to avoid last minute confusion.
- What if a member of my family is opposed to the tissue donation?
The best way to ensure that your wishes are carried out is to tell your family how strongly you feel about being a tissue donor. You also should sign and carry a donor card and record your wishes in legal documents.
- What needs to be done when I have made a decision to become a donor?
- Discuss your decision with your family and agent with Medical Power of Attorney so they will understand and support your decision.
- Sign the tissue donor form included in this brochure.
- Send a copy to your next of kin, your family doctor, the intended executor of the estate,the agent under Medical Power of Attorney, the KDA and the University of Michigan Brain Bank at the address shown on the front of this brochure.
- Keep a copy of the document with your other legal documents.
- Sign the Tissue Donor Card included in this brochure and carry it in your wallet.
- Ask your family doctor to recommend a suitable hospital, medical center, or pathologist.
- How do we minimize any last minute decisions or conflicts?
Preplanning is required. If the decision is made to donate tissue at the time of death, the process becomes impossible to have the collection performed in a timely manner.
- Discuss your decision with your family and agent with Medical Power of Attorney so they will understand and support your decision.
- Discuss your decision with your family doctor.
- Ask your doctor to recommend a suitable hospital, medical center, or local pathologist where the harvesting of the tissue can be performed.
- Contact the hospital, medical center, or pathologist ahead of time; review with them your decision, and determine what the institution requires to perform the collection.
- Finally, discuss transportation requirements with the funeral home director.
- What tissue will be harvested?
Researchers recommend the following:
- The entire spinal cord
- Skeletal muscles
- Upper arm – 2”
- Upper leg – 2”
Other tissue that could also be useful for research:
- Brainstem
- Testes
What Needs To Be Done At The Time Of Death?
The responsible family member or legal guardian should oversee the final arrangements of thedeceased. The following checklist shows the steps to follow:
1.Notify the donor's attending doctor. If death occurs at home, the doctor, nurse,or funeral director can provide the phone numbers for the local agencies that need to be notified.
2.Notify the pathologist, hospital or medical center where the collection is to take place. After notification, the funeral director can make transportation arrangements from the place of death to the medical center or local pathologist.
3.Call the Kennedy’s DiseaseTissue Bank Coordinator at 734-936-6267 Pager#9198. If unavailable, leave your area code and phone number(and cell phone number, if available) where you can be reached.Have the following information available:
•The name of the deceased as well as the date, time, and location of death.
•The deceased’s KDA registration number.
•Most recent medical history.
•Name and phone number of the funeral director.
•A copy of form A or B.
4.Contact the funeral director and hospital. Arrangements must be made totransport the body to the hospital, medical center or to the local pathologist where the tissue will be harvested. Forms A (or B), C, D and E need to be given to the pathologist.
Important: The body should not beembalmed and must be kept cool (4◦ C) until after the pathologist has collected the tissue.
5.Inform the pathologist of what tissue to harvest. Researchers recommend the following:
- The entire spinal cord
- Skeletal muscles
- Upper arm – 2”
- Upper leg – 2”
Other tissue that could be useful for research:
- Brainstem
- Testes
6.Provide verbal or written consent. The next of kin, agent with Medical Power of Attorney, or appointed legal guardian will receive a phone callfrom a medical center staff member asking for verbal consent to perform the tissue collection. Thiscall will be placed and witnessed or recorded by a medical center operator. If you are present at the medical center,you will sign a written consent form. The tissue collection should be completed and the body will be returned to the funeral home normally within 24 hours.
7.Continue with your funeral arrangements
The Forms You Need
- Form A:Provisional Consent for Pre-Arrangements by a Legally Competent Adult
This form states that it is the wish of the patient to donate tissue for research after death. It is not legally binding. A signed copy of this form should be placed in the Hospital, Doctor,and/or Nursing Home Medical Record.
- Form B:Provisional Request For a Patient Who Is Unable to Give Consent
This form allows a legal next-of-kin, the intended executor of the estate, or the agent under Medical Power of Attorney to give provisional consent for the tissue collection, if the donor is unable to communicate this decision. This form states the wishes of the next-of-kin, the intended executor of the estate, or the agent under Medical Power of Attorney only, and is not legally binding. A signed copy of this form should be placed in the donor’s medical record at the Hospital, Doctor’s office, and/or Nursing Home.
The KDA must receive a signed copy of Form Aor B for enrollment in the Tissue Donation Program. When you send a signed copy to the KDA, we will acknowledge receipt of your request by sending you an enrollment letter. You should keep the forms with this booklet. The legal next-of-kin, the intended executor of the estate, or the agent under Medical Power of Attorneywill still need to give permission for the tissue collection at the time of death. Depending on the circumstances, permission will be given verbally, as described on the previous page (step 4), or by completing a written form at the medical center.
- Form C: Nursing Information on Postmortem Procedure
This form describes the procedures for the nursing staff to follow after the patient has died. A copy of this form should be placed in the patient’s chart along with Form E, every time the patient is admitted to a hospital or nursing care facility. It should be given to the funeral director to take with the body to the medical center, university, or local pathologist.
- Form DPatient Medical History at Death
This form is placed in the donor's chart along with Form C. It documents the date and time of the patient's death. The doctor or nursing staff should complete it. The form also records the donor’s medical history. The donor’s nurse and family should fill it out as completely as possible. It should be given to the funeral director to take with the body to the medical center, university, or the local pathologist.